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1 27027 Tour ney Road Valencia, CA Test Updates December 25, 2010 Dear Colleague: Please review the following specific test listings for important information about new assay availability and test revisions. Each upcoming change also provides an effective date to assist in the prioritization of any changes necessary to your own ordering systems. If you are not also receiving this information via , please contact our Client Relations team at to be added to our electronic mailing list. As a reminder, Specialty will be changing its name on January 25, Nothing changes for you from a service perspective. You may have noted that we have begun transitioning the way that we answer calls, however most of the changes will take several months to implement. According to federal regulation, we will change to the Quest Diagnostics Nichols Institute name on all patient data documentation, including laboratory reports, on the effective date in January. In 2011 we will continue our focus on providing better turnaround times for our time sensitive assays. The TAT for the Triple and Quad Marker will be changing from three to two. In order for the decreased TAT to be evident to your clients it is imperative that the patient information be provided at the time of order since this information is critical to the finalization of the results. If the information is not provided, the TAT will be delayed while Specialty contacts you to ascertain the information. We appreciate your assistance in proactively providing the demographic requirements for these assays. We are pleased to inform you that a number of our tests are now New York approved. Serum tests include Clonazpem [4918], Cocaine Metabolites [4118], Flurazepam (Dalmane ) [4920], Lorazepam [4087], Triazolam [4089], Temazepam [4088], Oxazepam [4934], Nordiazepam [4928], Midazolam [4085], Chlordiazepoxide [4916], Leflunomide Metabolite [4191], and Benzodiazepines Screen [4090]. In addition, Nicotine & Cotinine [4190 & 4190U respectively] performed on serum and urine are New York approved for testing. The American Medical Association (AMA) has made CPT code changes in the 2011 edition of the AMA Current Procedural Terminology (CPT) coding manual. Specialty Laboratories will be implementing these changes effective January 1, Overall, the changes for 2011 affect the way we bill some of our tests. We have posted the chart listing the tests affected and the appropriate CPT code changes on our website for ease of reference. We thank you for choosing Specialty and look forward to your continued support. For additional information, please visit our Web site at or contact Client Relations at Respectfully Yours, Basel Kashlan, MD, FCAP Laboratory Director

2 New Tests (Specialty): 1712 Phosphatidylserine IgG Autoabs (Available January 31) Method /Units Phosphatydilserine IgG EIA <11.0 GPS U/mL Serum 2.0 (0.6) ml: Refrigerated 7, Frozen 2 months Sunday, Tuesday - Saturday Same day CPT Code Regulatory Status FDA Approved 1713 Phosphatidylserine IgM Autoabs (Available January 31) Method /Units Phosphatydilserine IgM EIA <25.0 MPS U/mL Serum 2.0 (0.6) ml: Refrigerated 7, Frozen 2 months Sunday, Tuesday - Saturday Same day CPT Code Regulatory Status FDA Approved 1714 Phosphatidylserine IgA Autoabs (Available January 31) Method /Units Phosphatydilserine IgA EIA <20.0 APS U/mL Serum 2.0 (0.6) ml: Refrigerated 7, Frozen 2 months Sunday, Tuesday - Saturday Same day CPT Code Regulatory Status FDA Approved 4085U Midazolam, Urine (Available January 31) Method /Units Midazolam Urine LC-MS-MS <100 ng/ml Urine 6.0 (4.0) ml: Refrigerated 14, Frozen 14 Collection Instructions Collect random urine in a urine collection cup. No preservative is needed. Ship refrigerated or frozen. Specimens contaminated with blood (RBC 3+) will be rejected. Tuesday, Thursday, Saturday Within 2 CPT Code Regulatory Status Laboratory Developed Test Always Statement Limit of quantitation: Midazolam 100 ng/ml 2 of 20

3 New Tests (Specialty): (cont d) 4087U Lorazepam, Urine (Available January 31) Method /Units Lorazepam Urine LC-MS-MS <100 ng/ml Urine 6.0 (4.0) ml: Refrigerated 14, Frozen 14 Collection Instructions Collect random urine in a urine collection cup. No preservative is needed. Ship refrigerated or frozen. Specimens contaminated with blood (RBC 3+) will be rejected. Tuesday, Thursday, Saturday Within 2 CPT Code Regulatory Status Laboratory Developed Test Always Statement Limit of quantitation: Lorazepam 100 ng/ml 4691U Pain Management Heroin Metabolite Screen w/confirm, Urine (Available January 31) Method Cut-off/Units Heroin Metabolite EIA Negative 6 Acetylmorphine LC-MS-MS 10 ng/ml Urine 20 (7) ml: Ambient 7, Refrigerated 14, Frozen 30 Collection Instructions Collect 20 ml of random urine. Ship ambient. Tuesday - Saturday Next day CPT Code Regulatory Status FDA Approved Note Limit of screen quantitation: 10 ng/ml. Confirmation testing will automatically be performed on all Positive screen results for an additional charge (add CPT code 83925). 8947NY Borrelia burgdorferi IgG Abs w/reflex + Bands [NY] (Available January 31) Method /Units B. burgdorferi IgG Abs EIA <0.80 Index Serum 2.0 (1.0): Ambient 7, Refrigerated 14, Frozen 2 months Sunday, Tuesday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement REFERENCE RANGE for B. burgdorferi IgG Abs: Less than 0.80 Index... Negative Index..... Equivocal Greater than 1.19 Index.. Positive Note If positive, B. burgdorferi IgG immunoblot panel (New York criteria), code 7712BNY, is performed for An additional fee (add CPT code 86617). Clinical Utility Aid in the diagnosis of infection with the Lyme disease agent. 3 of 20

4 New Tests (Specialty): (cont d) 8948NY Borrelia burgdorferi IgM Abs w/reflex + Bands [NY] (Available January 31) Method /Units B. burgdorferi IgM Abs EIA <0.80 Index Serum 2.0 (1.0): Ambient 7, Refrigerated 14, Frozen 2 months Sunday, Tuesday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement REFERENCE RANGE for B. burgdorferi IgM Abs: Less than 0.80 Index... Negative Index..... Equivocal Greater than 1.19 Index.. Positive Note If positive, B. burgdorferi IgM immunoblot panel (New York criteria), code 7714BNY, is performed for an additional fee (add CPT code 86617). Clinical Utility Aid in the diagnosis of infection with the Lyme disease agent. 7712BNY Borrelia burgdorferi IgG + Bands [NY] (Available January 31) Method B. burgdorferi IgG Abs Negative p18 p23 p28 p30 p39 p41 p45 p58 p66 p93 Serum 1.0 (0.5): Ambient 7, Refrigerated 14, Frozen 2 months Monday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement INTERPRETIVE CRITERIA: POSITIVE: Lyme IgG is considered as POSITIVE by the New York State Dept. of Health if any FIVE of the following bands are Present: 18, 23, 28, 30, 39, 41, 45, 58, 66 or 93 kd INDETERMINATE: New York State Dept. of Health considers the test results as INDETERMINATE if ONE to FOUR bands are Present. NEGATIVE: No bands present. Note Sera from individuals, with other pathogenic spirochetal diseases such as syphilis, yaws, pinta, leptospirosis, relapsing fever and periodontal disease, may give false positive results. Individuals with connective tissue autoimmune diseases such as rheumatoid arthritis and systemic lupus erythromatosis, and individuals with anti-nuclear antibody may also give false positive results. Individuals with other bacterial and viral infections such as Rocky Mountain Spotted Fever, Epstein- Barr Virus, and Cytomegalovirus may also have antibodies which cross-react with B. burgdorferi. Clinical Utility There are multiple criteria for interpreting Lyme immunoblots. The "New York State" criterion provides an indeterminate interpretation in addition to a positive and negative interpretation. For interpretation of an IgG positive blot, at least 5 of 10 IgG bands (18, 23, 28, 30, 39, 41, 45, 58, 66 or 93 kda) must be present. An indeterminate IgG blot is interpreted by the presence of 1 to 4 IgG bands (18, 23, 28, 30, 39, 41, 45, 58, 66 or 93 kda). Positive, indeterminate and negative results are reported. 4 of 20

5 New Tests (Specialty): (cont d) 7714BNY Borrelia burgdorferi IgM + Bands [NY] (Available January 31) Method B. burgdorferi IgM Abs Negative p23 p39 p41 Serum 1.0 (0.5): Ambient 7, Refrigerated 14, Frozen 2 months Monday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement INTERPRETIVE CRITERIA: POSITIVE: Lyme IgM is considered as POSITIVE by the New York State Dept. of Health if any TWO of the following bands are Present: 23, 39 or 41 kd. INDETERMINATE: New York State Dept. of Health considers the test results as INDETERMINATE if ONE band is Present. NEGATIVE: No bands present. Caution must be used in supporting a diagnosis of B. burgdorferi infection when sera are immunoblot IgM positive and immunoblot IgG negative after the initial 4 week period from onset. Because the likelihood of a false-positive test result is high for these individuals, a positive IgM test alone is not recommended for use in determining active disease in persons with illness longer than one month duration. Note Sera from individuals, with other pathogenic spirochetal diseases such as syphilis, yaws, pinta, leptospirosis, relapsing fever and periodontal disease, may give false positive results. Individuals with connective tissue autoimmune diseases such as rheumatoid arthritis and systemic lupus erythromatosis, and individuals with anti-nuclear antibody may also give false positive results. Individuals with other bacterial and viral infections such as Rocky Mountain Spotted Fever, Epstein- Barr Virus, and Cytomegalovirus may also have antibodies which cross-react with B. burgdorferi. Clinical Utility There are multiple criteria for interpreting Lyme immunoblots. The "New York State" criterion provides an indeterminate interpretation in addition to a positive and negative interpretation. For interpretation of an IgM positive blot, at least 2 of 3 IgM bands (23, 39 or 41 kda) must be present. An indeterminate IgM blot is interpreted by the presence of only 1 of 3 IgM bands (23, 39 or 41 kda). Positive, indeterminate and negative results are reported. New Tests (Specialty): (cont d) 5 of 20

6 2523 Influenza Virus, Type A Detection [DFA] (Available January 31) Method Specimen Source Influenza A Antigen DFA Not detected Smear/Slides 4 (2): Ambient 48 hours, Refrigerated 72 hours, Frozen 7 Alt Specimen Culturette/Swab: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 M4 Transport Media/Swab: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Sterile Container/Tube: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Swab Viral Transport: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Viral Transport Media: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Collection Instructions 1. Source of specimen is required, please include on requisition. 2. Specimens should be collected early in the acute phase of infection. The chance of viral recovery is best during the first 3 after onset and is greatly reduced beyond 5 with many viruses. 3. Submit 2 acetone-fixed slides or specimens in viral transport media. These specimens are from respiratory sources such as nasal swab or washings. 4. Unacceptable specimens: Wooden swabs, dry swabs and calcium alginate. 5. Specimens received more than 72 hours from time of draw must be frozen at -70C (not -20C) or on dry ice. Do not freeze at -20 C. Virus loses infectivity. 6. Ship specimens on cold pack or on dry ice. 7. M4 transport media (M4) and dacron-tipped swabs with plastic or fine-wire shafts available for use with M4 are provided. 8. Ship specimens on cold pack or on dry ice. Sunday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement For negative influenza antigen results, cell culture should be considered to confirm the results or to identify other viruses producing similar clinical symptoms. Note Tests available for other respiratory viruses are #2425 Respiratory Infection Evaluation, Viral and #2503 Viral Culture, Respiratory. Clinical Utility Aid in the diagnosis of influenza A viruses which can cause highly contagious respiratory diseases and typically results in epidemics. 6 of 20

7 New Tests (Specialty): (cont d) 2524 Influenza Virus, Type B Detection [DFA] (Available January 31) Method Specimen Source Influenza B Antigen DFA Not detected Smear/Slides 4 (2): Ambient 48 hours, Refrigerated 72 hours, Frozen 7 Alt Specimen Culturette/Swab: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 M4 Transport Media/Swab: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Sterile Container/Tube: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Swab Viral Transport: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Viral Transport Media: Ambient 24 hours, Refrigerated 72 hours, Frozen 7 Collection Instructions 1. Source of specimen is required, please include on requisition. 2. Specimens should be collected early in the acute phase of infection. The chance of viral recovery is best during the first 3 after onset and is greatly reduced beyond 5 with many viruses. 3. Submit 2 acetone-fixed slides or specimens in viral transport media. These specimens are from respiratory sources such as nasal swab or washings. 4. Unacceptable specimens: Wooden swabs, dry swabs and calcium alginate. 5. Specimens received more than 72 hours from time of draw must be frozen at -70C (not -20C) or on dry ice. Do not freeze at -20 C. Virus loses infectivity. 6. Ship specimens on cold pack or on dry ice. 7. M4 transport media (M4) and dacron-tipped swabs with plastic or fine-wire shafts available for use with M4 are provided. 8. Ship specimens on cold pack or on dry ice. Sunday - Saturday Same day CPT Code Regulatory Status FDA Approved Always Statement For negative influenza antigen results, cell culture should be considered to confirm the results or to identify other viruses producing similar clinical symptoms. Note Tests available for other respiratory viruses are #2425 Respiratory Infection Evaluation, Viral and #2503 Viral Culture, Respiratory. Clinical Utility Aid in the diagnosis of influenza B viruses which can cause highly contagious respiratory diseases and typically results in epidemics. 7 of 20

8 Test Changes: 1081 Antiphospholipid Syndrome EvaluatR Effective Immediately #1 Plasma Citrated 2.0 (1.0) ml: Frozen 14 #2 Serum 2.0 (1.0) ml: Refrigerated 7, Frozen 2 months Note: Increased frozen serum stability Beta-2-Glycoprotein I (Beta-2-GPI) IgG, IgM & IgA Autoabs Effective Immediately Serum 1.0 (0.6) ml: Ambient 14, Refrigerated 28, Frozen 2 months Note: Increased frozen stability. Also Affected DOS Codes 1182, 1183, ANA w/international Units & Pattern Effective Immediately CPT Code (NEW) Also Affected DOS Codes 1000, 1004, 1006, 1010, 1100C, 1118, 1121, 1122, 1126, 1127, 1726, 1862, 1866, 1868, 5906, FLT3 & NPM1 GenotypR Effective Immediately Whole Blood EDTA 5.0 (3.0) ml: Ambient 7, Refrigerated 7, Frozen 7 Whole Blood ACD 5.0 (3.0) ml: Ambient 7, Refrigerated 7, Frozen 7 Whole Blood Heparin 5.0 (3.0) ml: Ambient 7, Refrigerated 7, Frozen 7 Bone Marrow EDTA 1.5 (0.5) ml: Ambient 7, Refrigerated 7, Frozen 7 Bone Marrow ACD 1.5 (0.5) ml: Ambient 7, Refrigerated 7, Frozen 7 Bone Marrow Heparin 1.5 (0.5) ml: Ambient 7, Refrigerated 7, Frozen 7 Cell Pellet: Ambient 6 months Note: Frozen specimens now accepted Lupus Anticoagulant: Hexagonal Phase Effective January 1 CPT Code (NEW) Also Affected DOS Codes 1910, 5962, Glutamic Acid Decarboxylase (GAD) Autoabs Effective February 8 <1.1 U/mL (NEW) Also Affected DOS Code Glomerular Filtration Rate (GFR), Estimated Effective February 8 Always Statement The National Kidney Foundation defines the stages of CKD based on the GFR: Stage Description GFR[ml/min/1.73m2] 1 Kidney damage with normal or increased GFR >=90 2 Kidney damage with mildly decreased GFR Moderately decreased GFR Severely decreased GFR Kidney failure <15(or dialysis) Source: 1. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. Am J Kidney Dis 39:S1-S262, 2002 (suppl 1) 2. Levey AS, Stevens LA, Schmid CH, Zhang YL, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150: of 20

9 Test Changes: (cont d) 1760 Kappa/Lambda Light Chains, Free w/ratio, Serum Effective February 8 Kappa Free Light Chain mg/l (same) Lambda Free Light Chain mg/l (same) Kappa/Lambda Ratio (NEW) Always Statement Interpretation: In serum, kappa/lambda ratio of whole immunoglobulin molecules is 2:1, whereas the kappa/lambda ratio of free light chains is 1:1.5. The latter is attributed to the occurrence of lambda light chains as dimers whose serum 1/2-life is approximately 3 times longer than that of monomeric kappa light chains. Excess production of kappa or lambda light chains alters the kappa/lambda ratio. Alterations that fall outside the normal range are attributed to the presence of monoclonal light chains. Monoclonal light chains are found in serum of patients with multiple myeloma, the light chain variant of MM, Waldenstrom's macroglobulinemia, mu-heavy chain disease, primary amyloidosis, light chain deposition disease, monoclonal gammopathy of undetermined significance, and lymphoproliferative disease such as B-CLL. Measurement of free light chain concentration in serum is useful for diagnosis, prognosis, monitoring disease activity and following response to therapy of these disorders. Chronic infection and chronic inflammatory diseases, as well as renal insufficiency, may be accompanied by a diffuse increase in both kappa and lambda free chains, but kappa/lambda ratio remains within normal limits. The serum concentration of free light chains increases with age over 60 years; light chains may reach 50 mg/l in those yrs of age; in these cases the kappa/lambda ratio still remains within normal limits. Physicians, who are accustomed to the identification of clonal protein by electrophoretic means, may order immunofixation in addition to free light chain immunoassay. In rare instances, immunofixation may identify monoclonal light chain protein in the absence of abnormalities in the quantitative light chain immunoassay. Katzman JA et al., Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: Relative sensitivity for detection of monoclonal light chains. Clin Chem 2002, 48: Also Affected DOS Code Human Papillomavirus High Risk DetectR Effective February 8 Brush Qiagen (Digene) Medium 1.0 (1.0) ml: Ambient 14, Refrigerated 21, Frozen 3 months Alt Specimen ThinPrep Vial 8.0 (4.0) ml: Ambient 3 months, Refrigerated 3 months SurePath Vial 3.0 (2.0) ml: Ambient 30, Refrigerated 30 Tissue: Frozen 2 months Note: AutoCyte PREP Tubes are no longer accepted. Increased ambient and decreased refrigerated stability for SurePath Vials. Also affected DOS Codes 1820, 1822, Testosterone, Total Effective February 8 Always Statement In hypogonadal males, Testosterone, Total, LC/MS/MS is the recommended assay. This test code (15983) must be collected in a red-top tube with no gel. The Endocrine Society recommends obtaining at least two morning (8-10 a.m.) samples on different when screening for hypogonadism. Aging Men with clinically significant hypogonadal symptoms and testosterone values repeatedly in the range of ng/dl or less may benefit from testosterone treatment after adequate risk and benefits counseling. Also Affected DOS Codes 2017, 2023, 2025, 3188, 3248, 3916, of 20

10 Test Changes: (cont d) 4882UR 4900P Chromium Random Urine Effective February 8 Chromium Random Urine (ADD) <2.0 mcg/l Chromium/Creatinine Ratio (NEW NAME) <5.0 mcg/g creat (same) Amikacin, Peak & Trough Effective February 8 #1 Serum Peak 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma Heparin Peak 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma EDTA Peak 1.0 (0.5) ml: Ambient 5, Refrigerated 7 #2 Serum Trough 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma Heparin Trough 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma EDTA Trough 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Note: Plasma Heparin and EDTA specimens are now accepted; ambient specimens are now accepted; frozen specimens are no longer accepted. Collection Instructions Collect peak at end of 60 minute IV infusion, or 30 minutes after end of 30 minute infusion, or 60 minutes after IM dose. Collect trough immediately prior to next dose. Serum separator tubes are not acceptable. Moderate to grossly lipemic specimens will be rejected. Transport room temperature. Methodology Immunoassay (NEW) Peak: mg/l (NEW UNITS) Trough: mg/l (NEW UNITS) Always Statement Peak concentration: mg/l (collected min after injection) Trough concentration: mg/l (for less severe infection) mg/l (for more severe infection) Also Affected DOS Codes 4700P, 4700P 4900 Amikacin Effective February 8 Serum 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma Heparin 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Plasma EDTA 1.0 (0.5) ml: Ambient 5, Refrigerated 7 Note: Plasma Heparin and EDTA specimens are now accepted; ambient specimens are now accepted; frozen specimens are no longer accepted. Collection Instructions Collect peak at end of 60 minute IV infusion, or 30 minutes after end of 30 minute infusion, or 60 minutes after IM dose. Collect trough immediately prior to next dose. Serum separator tubes are not acceptable. Moderate to grossly lipemic specimens will be rejected. Transport room temperature. Methodology Always Statement Immunoassay (NEW) Peak concentration: mg/l (collected min after injection) (NEW UNITS) Trough concentration: mg/l (for less severe infection) (NEW UNITS) mg/l (for more severe infection) (NEW UNITS) 8766 Varicella-Zoster Virus Antibody (IgM) Effective February 8 Serum 1.0 (0.5) ml: Ambient 7, Refrigerated 14, Frozen 30 Note: Decreased frozen stability. 10 of 20

11 Test Changes: (cont d) 1305UR 1320U 1320UR Protein, Total & Creatinine Urine Random w/ratio Urine 10 (2) ml: Ambient 4, Refrigerated 5, Frozen 28 Note: Increased refrigerated and decreased frozen stability. Collection Instructions 10 ml urine form a well-mixed random collection; no preservative. Transport at room temperature. Protein, Total Urine Random Male: 5-25 mg/dl (NEW) Female: 5-24 mg/dl (NEW) Creatinine Urine Random no change Protein/Creatinine Ratio Male: mg/g creat (NEW) Female: mg/g creat (NEW) Creatinine 24Hr Urine Urine 24 hour 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Acetic Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Boric Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. Creatinine Urine Random Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability Creatinine Clearance #1 Serum 1.0 (0.5) ml: Ambient 7, Refrigerated 7, Frozen 28 Plasma Haparin 1.0 (0.5) ml: Ambient 7, Refrigerated 7, Frozen 28 #1 Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen urine stability. 1324U 1324UR Protein, Total 24Hr Urine Urine 24 hour 10 (2) ml: Ambient 4, Refrigerated 5, Frozen 28 Note: Decreased ambient, refrigerated and frozen stability. Collection Instructions Do not include first morning specimen in 24-hour collections. Collect all subsequent voidings. The last sample collected should be the first specimen voided the following morning at the same time as the previous morning's first voiding or at the end of the collection period. Refrigerate during collection. Do not preserve. Total volume should be indicated on the requisition if collected overnight or during 24 hours. Transport at room temperature. < 150 mg/24 hr (NEW) Also Affected DOS Codes 1584U, 1595U (Reference ranges only) Protein, Total Urine Random Urine 10 (2) ml: Ambient 4, Refrigerated 5, Frozen 28 Note: Decreased ambient and refrigerated stability. Collection Instructions Pour a well-mixed aliquot of specimen into a clean leak-proof container. Collect without preservative. Transport at room temperature. Male: 5-25 mg/dl (NEW) Female: 5-24 mg/dl (NEW) Also Affected DOS Codes 1580U, 1584U, 1584UR, 1595U (Reference ranges only) 11 of 20

12 Test Changes: (cont d) 1324C 1328U 3441U 3441UR Protein, Total CSF CSF 1.0 (0.5) ml: Refrigerated 7, Frozen 6 months Note: Ambient specimens are no longer accepted; increased refrigerated and frozen stability. Collection Instructions Grossly hemolyzed specimens will be rejected. Transport refrigerated. < 29 Days: mg/dl (NEW) 29 Days 60 Year: mg/dl (same) > 60 Year: mg/dl (NEW) Also Affected DOS Codes 1580C, 1584C (Reference ranges only) Protein, Total w/creatinine 12-Hour Urine Urine 12 hour 10 (2) ml: Ambient 4, Refrigerated 5, Frozen 28 Urine Transport Tube 10 (2) ml: Ambient 4, Refrigerated 5, Frozen 28 Note: Decreased ambient, refrigerated and frozen stability. Collection Instructions 10 ml 12-Hour Urine Instructions: 10 ml aliquot from a well-mixed, 12-hour urine collection, no preservatives. Record 12-hour urine volume on test request form and urine vial. Transport at room temperature. Microalbumin 24Hr Urine Urine 24 hour 10 (2) ml: Ambient 7, Refrigerated 14, Frozen 1 year Note: Frozen specimens now accepted; increased ambient stability. Collection Instructions Submit 10 ml aliquot from a well-mixed 24-hour urine, submitted in a plastic, leakproof container. Do not use preservatives. Record 24-hour urine volume on test request form and urine container. Transport at room temperature. Methodology Turbidimetric (New) Microalbumin, 24 Hour Urine (ADD) < 30 mg/24 hr (NEW) Microalbumin, 24 Hour Urine (NEW NAME) < 20 mcg/min (NEW) Microalbumin Urine, ug/ml (REMOVE) Creatinine Urine (no change) Microalbumin Urine Random Name Microalbumin, Random Urine (w/creatinine) (NEW) Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Frozen specimens now accepted; increased ambient and decreased refrigerated stability. Collection Instructions 10 ml aliquot from unpreserved urine, random submitted in a plastic leak-proof container. Transport at room temperature. Methodology Turbidimetric (New) Microalbumin Urine (REMOVE) Microalbumin/Creatinine Ratio < 30 mcg/mg (NEW UNITS) Creatinine Urine (no change) 12 of 20

13 Test Changes: (cont d) 4332U 4332UR 4333U 4333UR Oxalate 24Hr Urine Name Oxalic Acid, 24-Hour Urine (NEW) Urine Preserved (6N HCl) 24 hour 10 (2) ml: Ambient 6, Refrigerated 7, Frozen 4 months Note: Increased frozen stability; decreased ambient stability. Collection Instructions Patient should refrain from taking excessive amounts of Ascorbic Acid or Oxalate-rich foods (i.e., spinach, coffee, tea, chocolate, rhubarb) for at least 48 hours before the collection period. Collect urine with 25 ml 6N HCl to maintain a ph below 3. Specify 24 hr urine volume on the requisition. Transport at room temperature mg/24 hr (NEW) Also Affected DOS Code 4168 (Reference ranges only) Oxalate Urine Random Name Oxalic Acid, Random Urine (NEW) Urine Preserved (6N HCl) 10 (2) ml: Ambient 6, Refrigerated 7, Frozen 4 months Urine Transport Tube 10 (2) ml: Ambient 13, Refrigerated 13, Frozen 28 Note: Increased frozen stability; decreased ambient stability. Collection Instructions Patient should refrain from taking excessive amounts of Ascorbic Acid or Oxalate-rich foods (i.e., spinach, coffee, tea, chocolate, rhubarb) for at least 48 hours before the collection period. Collect urine with 25 ml 6N HCl to maintain a ph below 3. Transport at room temperature. Uric Acid 24Hr Urine Urine 24 hour 10 (2) ml: Ambient 13, Refrigerated 13, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 13, Refrigerated 13, Frozen 28 Note: Increased ambient stability; decreased refrigerated and frozen stability. Collection Instructions Do not acidify the urine. Please aliquot for uric acid testing prior to addition of any acid for those tests requiring preservative. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first morning specimen voided the following morning at the same time as the previous morning's first voiding. Specify total volume and duration of collection on container and test requisition. Transport at room temperature. Male: mg/24 hr (NEW) Female: mg/24 hr (NEW) Also Affected DOS Code 4168 (Reference ranges only) Uric Acid Urine Random Urine 10 (2) ml: Ambient 13, Refrigerated 13, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 13, Refrigerated 13, Frozen 28 Note: Increased ambient stability; decreased refrigerated and frozen stability. Collection Instructions 10 ml urine aliquot from a random urine collection. No preservatives. Instructions: Collect urine without preservative. Do not acidify the specimen. Transport at room temperature is preferred; transport refrigerated (cold packs) or frozen is acceptable. Always Statement Reference ranges are not available for random collections. 13 of 20

14 Test Changes: (cont d) 4836U 4836UR 4866U 5304U 5304UR Calcium 24Hr Urine Urine Preserved (6N HCl) 24 hour 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Urine 24 hour 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Urinalysis Transport Tube 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Note: Increased refrigerated and frozen stability; decreased ambient stability. Collection Instructions 24 hour urine: Do not include first morning specimen in 24-hour collection. Collect all subsequent voidings. The last sample collected should be the first specimen voided the following morning at the same time as the previous morning's first voiding. Collect urine with 25 ml of 6N HCL to maintain a ph below 3. It is acceptable to add preservative after collection if urine is refrigerated during collection. Adjust ph to <3. Record the total volume of urine on the requisition. Transport at room temperature. Methodology Spectrophotometry (NEW) Male: mg/24 hr (NEW) Female: mg/24 hr (NEW) Always Statement Low Calcium Diet: Males: mg/24 hr Females: mg/24 hr Also Affected DOS Code 4168 (Reference ranges only) Calcium Urine Random Urine Preserved (6N HCl) 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Urine 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Urinalysis Transport Tube 10 (2) ml: Ambient 5, Refrigerated 5 weeks, Frozen 6 months Note: Increased refrigerated and frozen stability; decreased ambient stability. Collection Instructions Collect 10 ml random urine in a plastic, screw-capped container and adjust ph to < 3.0 with 6N HCl (Minimum: 2 ml). Aliquot urine specimens and send at room temperature to the laboratory. Methodology Spectrophotometry (NEW) Always Statement Reference ranges are not available for random collections. Magnesium 24Hr Urine mg/24 hr (NEW) Also Affected DOS Codes 4168 Chloride with Creatinine, 24-Hour Urine Urine 24 hour 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Acetic Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Boric Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. Chloride with Creatinine, Random Urine Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. 14 of 20

15 Test Changes: (cont d) 5307U 5307UR 5308U 5308UR 5312U Sodium with Creatinine, 24-Hour Urine Urine 24 hour 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Acetic Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Boric Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. Sodium with Creatinine, Random Urine Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. Phosphorus 24Hr Urine Urine Preserved (6N HCl) 24 hour 10 (2) ml: Ambient 6 months, Refrigerated 6 months, Frozen 6 months Urine 24 hour 10 (2) ml: Ambient 48 hours, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 6 months, Refrigerated 6 months, Frozen 6 months Note: Increased ambient, refrigerated and frozen stability if preserved. Collection Instructions Collect urine with 25 ml of 6N HCL to maintain a ph below 3. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first morning specimen voided the following morning at the same time as the previous morning's first voiding. Specify 24-hour total volume on container and test requisition. Transport at room temperature. Male: mg/24 hr (NEW) Female: mg/24 hr (NEW) Also Affected DOS Code 4168 (Reference ranges only) Phosphorus Urine Random Urine Preserved (6N HCl) 10 (2) ml: Ambient 6 months, Refrigerated 6 months, Frozen 6 months Urine 10 (2) ml: Ambient 48 hours, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 6 months, Refrigerated 6 months, Frozen 6 months Note: Increased ambient, refrigerated and frozen stability if preserved. Collection Instructions Random urine: 10 ml random urine, adjust ph to < 3.0 with 6N HCL before aliquoting for phosphate testing. Transport at room temperature. Unpreserved urine: Keep urine refrigerated during and after collection and send frozen. Transport at room temperature. Always Statement Reference ranges are not available for random collections. Potassium with Creatinine, 24-Hour Urine Urine 24 hour 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Acetic Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urine Boric Acid 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. 15 of 20

16 Test Changes: (cont d) 5312UR Potassium with Creatinine, Random Urine Urine 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Urinalysis Transport Tube 10 (2) ml: Ambient 7, Refrigerated 7, Frozen 28 Note: Decreased refrigerated and frozen stability. The CPT Codes provided are based on AMA Guidelines and are for informational purposes only. CPT Coding is the sole responsibility of the billing party. Please direct any questions regarding CPT Coding to the payer being billed. 16 of 20

17 New Referral Tests: The following tests are now available from Quest Diagnostics and may be referred through Specialty Laboratories. S52249N-METANEPHRINES (RANDOM) (14961X) (NY) Test performed at Quest Diagnostics, San Juan Capistrano S52251N-VANILLYLMADELIC ACID, RANDOM URINE [1710][NY] Test performed at Quest Diagnostics, San Juan Capistrano S52268-FISH, DUPLICATION 22Q11.2 [16672X] Test performed at Quest Diagnostics, San Juan Capistrano S52308-B-CELL GENE REARRANGEMENT, QUANT. PCR, CELL-BASED [16005X] Test performed at Quest Diagnostics, San Juan Capistrano S52309-VON WILLEBRAND FACTOR COLLAGEN BINDING ASSAY [10924X] Test performed at Quest Diagnostics, San Juan Capistrano S52312-CAH PANEL 6B (COMPREHENSIVE SCREEN) [10299X] Test performed at Quest Diagnostics, San Juan Capistrano S52314-MUMPS VIRUS RNA, QUAL R-T PCR [49930] S52315-CHLAMYDIA TRACHOMATIS/PSITTACI CULTURE [81025] S52316-ANTIMICROBIAL SUSCEPTILITY, AFB, IMIPENEM [51200] S52317-ANTIMICROBIAL SUSCEPTILITY - DORIPENEM [51330] S52318-ANTIMICROBIAL SUSCEPTILITY - CARBENICILLIN [51330] S52319-ANTIMICROBIAL SUSCEPTILITY - GENTAMICIN [51330] S52320-ANTIMICROBIAL SUSCEPTILITY - CEFAZOLIN [51330] S52321-ANTIMICROBIAL SUSCEPTILITY - CEFEPIME [51330] S52322-SHIGELLA SEROTYPING [52185] S52323-MYCOPLASMA PNEUMONIAE ANTODY, CF (SERUM) [40730] S52324-ANTIMICROBIAL SUSCEPT. AFB, MOXIFLOXACIN [51200] 17 of 20

18 New Referral Tests: (cont d) S52325-ANTIMICROBIAL SUCEPTILITY, AFB, TIGECYCLINE [51200] S52326-CHIKUNGUNYA VIRUS RNA, QUAL RT-PCR [45606] S52328-ANTIMICROBIAL SUSCEPTILITY - CEPHALEXIN [51330] S52329-TOXOPLASMA GONDII IGG AVIDITY (AVIDX(TM)), ELISA [40927] S52330-ANTIMICROBIAL SUSC, AEROBIC BACTERIA, CUSTOM MIC (2) [51340] S52332-ANTIMICROBIAL LEVEL, RIFABUTIN, HPLC [51949] S52333-CYTOMEGALOVIRUS (CMV) DNA, QUANT RT PCR [45050] S52334-TOXOPLASMA GONDII DNA, QUANT RT PCR [45600] S52335-CHIKUNGUNYA ANTODIES WITH REFLEX(ES) TO TITER [40680] S52336-TREPONEMA PALLIDUM DNA, QUAL RT PCR [47020] S52337-MAG ANTODY, DUAL ELISA (SERUM) [21004][NY] S52338-ANTIFUNGAL SUSCEPT., MOLD, CUSTOM (2) MIC PANEL [53620] S52340-ANTIMICROBIAL SUSC, AEROBIC BACTERIA, CUSTOM MIC (3) [51350] S52341-ANTIMICROBIAL SUSC, AEROBIC BACTERIA, CUSTOM MIC (4) [51360] S52342-CHLAMYDIA GROUP ANTODY SCREEN, IFA (SERUM) [40265] S52343-BORRELIA BURGDORFERI IGG & IGM AB PANEL, IFA SER [40677] S52344-BARTONELLA ANTODY PANEL, IFA (CSF) [6020] S52345-ASPERGILLUS ANTODY PANEL, CF AND ID (SERUM) [2305] 18 of 20

19 New Referral Tests: (cont d) S52346-HISTOPLASMA ANTODY PANEL CF, ID AND ELISA [4490] S52347-INFLUENZA A VIRUS H1/H3 SUBTYPING BY REAL-TIME RT-PCR[42690] Please call client relations at or visit our website at for ordering information. 19 of 20

20 Discontinued Tests: Effective Immediately: S48545-Paroxysmal Nocturnal Hemoglobin Profile [95864] Recommended replacement: S52351-PNH WITH FLAER [16433] Test performed at Quest Diagnostics, San Juan Capistrano S52042-CD55 and CD59 Expression, Red Cells & Gran. [19835X] Recommended replacement: S52351-PNH with FLAER [16433] Test performed at Quest Diagnostics, San Juan Capistrano S51445-Prazepam (39776R) No replacement Effective January 15: 4984 Hemoglobin Variant Screen w/reflex Electrophoresis Recommended replacement: 4983 Hemoglobinopathy Evaluation Test performed at Specialty Laboratories Effective January 25: 5382 Cytochrome P450 2C19 (Clopidogrel) GenotypR Recommended replacement: S AccuType CP, Clopidgrel CYP2C19 Genotype [16924] Test performed at Quest Diagnostics Nichols Institute, San Juan Capistrano Effective January 31 S48335-MIDAZOLAM URINE [3057U] Recommended replacement: 4085U Midazolam, Urine Test performed at Specialty Laboratories S49504-LORAZEPAM URINE [2535] Rcommended replacement: 4087U Lorazepam, Urine Test performed at Specialty Laboratories 20 of 20